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Analysis of Visual Pathways in Glaucoma Patients Using a 3tesla-MRI (ENVOL)

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ClinicalTrials.gov Identifier: NCT01621841
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.


Condition or disease
Glaucoma Fractional Anisotropy

Study Design

Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : June 2012
Primary Completion Date : June 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Glaucoma subjects
heathly subjects


Outcome Measures

Primary Outcome Measures :
  1. fractional anisotropy [ Time Frame: Inclusion ]

Secondary Outcome Measures :
  1. volume of retrochiasmatic grey matter [ Time Frame: Inclusion ]
  2. global atrophy [ Time Frame: inclusion ]
  3. hyper intensities white matter [ Time Frame: inclusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Glaucoma subjects are recruted in ophtalmologic departement
Criteria

Inclusion Criteria:

  • for cases : Age over 40 years-old, glaucomatous lesion of the optic nerve head with cup/disc ratio, visual field loss, and minimental state superior or equal to 28/30
  • for healthy subjects/ matched on age and sex, no individual or familial history of glaucoma, IOP less than 21mmHG, minimental state superior or equal to 28/30

Exclusion Criteria:

  • Ocular hypertension, optic nerve disease, visual field loss, diabetes, Horton disease, ocular diseases, immunologic diseases, neuropsychiatric diseases, MRI contraindication (pace maker)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621841


Locations
France
Service d'ophtalmologie Hôpital Pellegrin
CHU de Bordeaux, Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Union National des Aveugles et DEficients Visuels
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01621841     History of Changes
Other Study ID Numbers: CHUBX2012/01
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases